Trial Information

Summary: A Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept

The purpose of this study is to test the safety and effectiveness of Infliximab (Remicade®) in patients with plaque psoriasis who have been receiving the drug etanercept for treatment of their plaque psoriasis for at least four months, without enough improvement in their psoriasis symptoms. Infliximab is approved for treating plaque psoriasis. However, infliximab has never before been tested in patient who are not responding well to etanercept. This study will tell us if these patients' psoriasis symptoms get better when they switch from etanercept to infliximab.

Inclusion Criteria:

• Have plaque psoriasis despite at least 4 months of treatment with etanercept per current US product labeling
• Have psoriatic target lesions that have a PGA score greater than 1 (minimal) at screening
• Are 18-75 years old
• If receiving methotrexate at screening, must have received methotrexate for at least 3 months and at a stable dose of <= 25 mg/week for at least 4 weeks prior to screening
• If receiving cyclosporine at screening, must have received cyclosporine at a stable dose of <= 5 mg/kg daily for at least 4 weeks prior to screening

Exclusion Criteria:

• Have already received infliximab or adalimumab
• Have shown a previous immediate hypersensitivity response, including anaphylaxis, to an immunoglobulin product
• Have a history of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to screening
• Have a concomitant diagnosis or any history of Congestive Heart Failure
• Are pregnant, nursing, or planning pregnancy
• Have used systemic corticosteroids within the 4 weeks prior to screening
• Have used topical corticosteroids or have initiated treatment with other topical therapies that could affect psoriasis or Psoriasis Area and Severity Index (PASI) evaluation (e.g., tar, anthralin, calcipotriene, tazarotene, methoxsalen) within 2 weeks prior to screening
• Have used new systemic agents/treatments, other than methotrexate, that can affect psoriasis including, but not limited to, immunosuppressants and/or psoralen plus ultraviolet A light (PUVA) within the 4 weeks prior to screening

For more information and to see if you qualify, please go to:

www.plaquepsoriasisstudy.com

Or call our toll-free number:

1-866-493-7484

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Trial listings updated: August 15, 2008 at 1:29:49 PM